MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children

Sanofi

Status and phase: Completed; Phase 3

Conditions: Fetal Growth Retardation

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452491

FH5126A

Details and patient eligibility

About

1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
2. To specify the best period of treatment
3. To assess the efficacy of treatment based on final adult height of these children

Enrollment: 306 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
• Height Less Than or Equal to -3 SD

Exclusion criteria

• Age less than 3 years

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

2

Active Comparator group

Treatment:

Drug: somatropin

Drug: somatropin